Archives: Resources
Lessons in Cell and Gene Therapies
A primer for understanding these remarkable therapies and their impacts in clinical trial.
Advancing Treatments for Chronic Kidney Disease and Rare Renal Disorders in Adults and Children
In this paper, we discuss our approach to this assessment and resulting findings and possibilities for future trajectories for treatment.
Recent Trends in Drug Safety: The Growing and Evolving Role of Real-World Evidence
Review evolving safety studies, recent FDA and EMA guidelines, regulatory shifts, new RWD approaches, and future post-marketing safety study expectations.
Overcoming Challenges in Real-World External Control Arm Design
Read our white paper on real-world external control arms design factors for ECAs to ensure minimal bias and results reflective of the investigated clinical outcomes.
The Evolution of Technology Enablement in Long-term Follow-up Studies
Explore how automated data capture and real-world data (RWD) technologies can optimize LTFU study design and improve real-world evidence (RWE) generation, addressing key challenges and enhancing study continuity.